Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)

Cardiovascular Diseases Clinical Trial

— Mobile4Heart  

Official title:

A Technology-Based Adaptive Intervention to Promote Cardiovascular Health After Completion of Cardiac Rehabilitation (Mobile4Heart)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446313
• Other study ID #: Mobile4Heart
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: April 5, 2019

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether using a mobile app increases adherence to a heart healthy prescription after discharge from a cardiac rehab program.

Description:

Ongoing maintenance of physical activity after cardiac rehab is an important part of preventing secondary cardiac events in patients with ischemic heart disease. Our central hypothesis is that monitoring and promotion of health-related behaviors by increasing patient-provider communication through a mobile device after discharge from cardiac rehab increased adherence to a heart healthy prescription over time. Participants will be randomly assigned to use a mobile app or serve as the control group. All participants will have an activity tracker to track their activity for two months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• History of cardiovascular disease that qualified patient for cardiac rehab (i.e. ischemic heart disease, history of unstable angina, systolic heart failure with ejection fraction at 35% or less, and Class II to IV symptoms, coronary artery bypass graft surgery, valve replacement)

• Own a smartphone or tablet

Exclusion Criteria:

• Cognitive impairment

• Lack of English proficiency/literacy

• Clinical conditions including: unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, symptomatic anemia, active infection, uncontrolled hypertension (resting diastolic > 100 mmHg, systolic > 180 mmHg), decompensated heart failure NYHA class 3-4, current unstable angina, 2nd or 3rd degree heart block, or uncontrolled high grade exercise-induced ventricular ectopy

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Heart Failure, Systolic
• Ischemic Heart Disease
• Myocardial Ischemia
• Systolic Heart Failure
• Unstable Angina

Intervention

Behavioral:
• Movn Mobile App
The Movn app will have each participant's personalized instructions for post-cardiac rehab integrated into it including medication reminders, physical activity prompts, educational materials, and patient-reported outcomes.

Locations

Country	Name	City	State
United States	John Muir Medical Center	Concord	California
United States	John Muir Medical Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Physical activity will be measured by an activity tracker.	Physical activity will be measured over the duration of two months.
Primary	Physical activity	Physical activity will be measured by a six minute walk test.	Physical activity will be measured over the duration of two months.
Secondary	Depression	Depression will be measured by the Patient Health Questionnaire-9 (PHQ-9). Scores can range from 5 to greater than 20 with 5 indicating minimal symptoms and 20 indicating severe major depression.	Depression will be measured at baseline and at month 2.
Secondary	Self-efficacy	Self-efficacy will be measured by the Exercise Self-Efficacy Scale (EXSE). Scores can range from 0-100 with 0 indicating no self-efficacy and 100 indicating high self-efficacy.	Self-efficacy will be measured at baseline and at month 2.
Secondary	Satisfaction with the app	Satisfaction with the app will be measured by interviewing a subset of participants.	Satisfaction will be measured at month 2 through individual interviews.